Daewoong Pharmaceuticals Collaborates with St. Mary’s Hospital to Seek Approval for Off-Label Use of Foistar Targeting COVID-19 Patient Cases

Daewoong Pharmaceuticals Collaborates with St. Mary’s Hospital to Seek Approval for Off-Label Use of Foistar Targeting COVID-19 Patient Cases

Could an existing drug for pancreatitis be used to target COVID-19?  Apparently, that’s a claim now unfolding in Korea as Daewoong Pharmaceuticals applied to market the drug known as Foistar (camostat mesylate) off-label in that nation. In Korea, off-label use targeting COVID-19 requires approval from the Health Insurance Review and Assessment Services (HIRA) and buy-in from an ethics committee and health regulators. Apparently, the company has already completed a Phase 2a clinical trial investigating the use of Foistar for mild COVID-19 patients at the end of last year. The results failed to achieve statistical significance but they were apparently associated with viral clearance. Korean Ministry of Food and Drug Safety thereafter approved a 300 patient Phase 2/3 clinical trial to start this month. In a search in clinicaltrials.gov, TrialSite found a Daewoong Pharmaceuticals’ Phase 3 clinical trial combining Foistar and Remdesivir involving 1,120 patients to start this month. Daewoong Pharmaceuticals declared it could possibly have interim results by mid-March 2021. In the meantime, the company elicited the support of St. Mary’s Hospital for an evaluation of the drug within 15 days of submission for use off-label. Assuming this evaluation is positive and meets all internal institutional review board (IRB) requirements, the esteemed medical center would apply for approval to HIRA.

COVID-19 in Korea—Sophisticated Contact Tracing Measures

With 51.2 million people the Republic of Korea (“South Korea” or “Korea”) has approximately 73,918 reported COVID-19 cases coupled with a reported 1,316 deaths. The country has experienced a worse second wave but nothing near the conditions occurring in places like America, the UK or Brazil for that matter. America and frankly many other nations could learn much from the Koreans about combating deadly pathogens such as SARS-CoV-2; in South Korea an elaborate, sophisticated contract tracing infrastructure tracks the entire population as reported in Undark. In fact, led by The Korea Disease Control and Prevention Agency (KDCA), established what’s called the “Epidemic Investigation Support System” as an infrastructure to support nationwide contact tracing efforts.

So sophisticated is this system that it can pull data from credit card transactions, cell phone locations and CCTV footage to basically reconstruct all sorts of infection pathways, allowing health authorities to identify individuals whose routes overlap, reported Wudan Yan and Ann Babe for Undark.

Enter Foistar

Now the prominent indigenous company Daewoong Pharmaceuticals seeks to access a sizable market and take the lead by achieving acceptance for off-label usage. Considerable stakes are now in play as, should the ministry and HIRA reject the application, the brand and reputation with the public would be in question.

In a recently completed study sponsored by Daewoong Pharmaceuticals, the team found a probable association of controlling inflammatory reactions and fever in COVID-19 patients with the drug. Moreover, the investigators observed no significant adverse events. They went on to declare that, “These results may encourage the use of Foistar as a treatment option for the patients with mild to moderate COVID-19.” The results were also shared in Europe PMCNo peer-review journal entries are available based on preliminary TrialSite search.

According to another entry in the Korea Medical Journal, this small study involved the comparison of 7 patients that took Foistar tablets with 22 patients who took Kaletra tablets (Lopinavir/ritonavir), the latter being an HIV treatment used in studies as a possible antiviral targeting COVID-19. This study was led by Professor Choi Jae-phil with the Department of Infectious Diseases at the Seoul Medical Center.

However, in a Phase 2 study, the Korea Herald reported that Daewoong Pharmaceuticals couldn’t prove that Foistar, also known as DWJ1248, statistically worked hence they continue with broader studies and will use it in combination with Gilead’s Remdesivir as reported in the Korea Herald. Daewoong Pharmaceuticals will commence a Phase 3 clinical trial to evaluate the combination of Foistar with Remdesivir in a bid to lower COVID-19 patient viral load.

The Phase 3 Trial

As disclosed in clincialtrials.gov, the sponsor (Daewoong) just now initiates “A Double-blind Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 with Remdesivir in Severe COVID-19 Patients” (NCT04713176) to assess the efficacy of Foistar. Targeting 1,120 patients, the sponsor will include two groups, including 1) a Foistar and Remdesivir group and 2) placebo and Remdesivir group.  In the study, they will evaluate the mortality rate and rate of use of extracorporeal membrane oxygenation (ECMO)  in the two groups for primary end points. A number of secondary end points include duration of hospitalization, recovery days, overall mortality rate and Desirable of Outcome ranking. This study will be conducted at about 70 trial site locations (mostly hospitals and including the National Medical Center in Korea for study of this drug).

The Quest for Off-Label Use: Lilly Request Declined in Korea

Recently writing for Korea Biomedical Review, Kim Chan-hyuk reports that American pharmaceutical company Eli Lilly made a similar move last May when they applied to have Olumiant (baricitinib), a rheumatoid arthritis treatment used off-label here in Korea. The government shot down that request due to the lack of sufficient evidence.

The Korean health authorities noted, “We have turned down the application because the submitted data only suggested theoretical possibilities screened by artificial intelligence (AI), and the data also lacked medical evidence to back up the drug’s clinical use.”

TrialSite will monitor to determine if Daewoong Pharmaceuticals has a similar fate to that of Lilly or if they alternatively establish a precedent for use of Foistar off-label.